Description
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “COVID-19: Developing Drugs and Biological Products for Treatment or Prevention.” The purpose of this guidance is to assist sponsors in the clinical development of drugs and biological products for the treatment or prevention of COVID-19. This guidance describes FDA’s current recommendations for phase 2 and phase 3 trials with a focus on trial population, trial design, efficacy endpoints, safety considerations, and statistical considerations. This guidance supersedes the guidance of the same name initially issued on May 19, 2020, and reissued on February 22, 2021.
Scope & Applicability
Product Classes
4Regulated under section 351(i) of the PHS Act; Virus, therapeutic serum, toxin, vaccine, or protein applicable to prevention or treatment; Alternative regulation category for products meeting device definition
drug where there has been no prior determination of safety or effectiveness
A type of ATMP involving recombinant nucleic acids or viral vectors.
Additional considerations may exist for cellular therapies.
Stakeholders
5Entity responsible for submitting applications under section 524B
Assist sponsors in the nonclinical evaluation
FDA division receiving next generation sequencing data
Data monitoring committee; Oversight body that may request interim analysis
Safety oversight body for interpreting adverse events; Safety oversight body for study design
Regulatory Context
Attributes
5Streamlined safety data collection category
The displayed oxygen saturation value which may have a range of uncertainty.; pulse oximeter oxygen saturation measurement; Functional oxygen saturation measured by the device; estimated oxygen level reading
FDA recommends sponsors categorize the baseline severity of COVID-19.
determine the neutralizing activity (half maximal effective concentration (EC50) value)
Antiviral activity measurement against variants
Related CFR Sections (2)
- 21CFR10.115§ 10.115 Good guidance practices.
(a) What are good guidance practices? Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents.Read full regulation →
- 21CFR312.32§ 312.32 IND safety reporting.
(a) Definitions. The following definitions of terms apply to this section:Read full regulation →
Related Warning Letters (10)
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Clinical Investigator
Shirish M. Gadgeel, M.D.
- 2025-07-15
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Mark J. Savant, M.D
- 2025-05-20
Bioresearch Monitoring Program/Institutional Review Board (IRB)
United Health Products, Inc.
- 2025-03-25
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Americo F. Padilla, M.D.
- 2024-11-05
Institutional Review Board (IRB)
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- 2024-10-22
Clinical Investigator
Namita A. Goyal, M.D.
- 2024-10-08
Institutional Review Board (IRB)
Louisiana State University Health Science Center IRB
- 2024-07-16
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Massachusetts Institute of Technology MIT
- 2024-03-26
Institutional Review Board (IRB)
New York State Psychiatric Institute IRB
- 2023-06-06
Investigational Device Exemptions (Clinical Investigator)
Mobeen Mazhar, M.D.
See Also (8)
- IRB Review of Stand-Alone HIPAA Authorizations Under FDA Regulations: Guidance for Industry (Status: Final)
- Acceptability of Draft Labeling to Support Abbreviated New Drug Application Approval; Guidance for Industry (Status: Draft)
- DSCSA Implementation: Product Tracing Requirements for Dispensers — Compliance Policy (Revised) Guidance for Industry (Status: Final)
- Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information: Guidance for Industry (Status: Final)
- Determining Donor Eligibility for Autologous Donors of Blood and Blood Components Intended Solely for Autologous Use - Compliance Policy: Guidance for Industry (Status: Final)
- Guidance for Industry: Use of the Term “Healthy” in the Labeling of Human Food Products (Status: Final)
- Revised Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products Who Have Received Human-Derived Clotting Factor Concentrates: Guidance for Industry (Status: Final)
- Guidance for Industry: Application of the Foreign Supplier Verification Program Regulation to the Importation of Live Animals (Status: Final)